Irritable Bowel SyndromeNCT06145022
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
A study testing lifestyle modification in people with Irritable Bowel Syndrome, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
In the planned efficacy study, a prospective randomized controlled trial will be conducted to investigate the extent to which a multimodal stress reduction and lifestyle modification program can be reflected in patients with irritable bowel syndrome (IBS) within the framework of a clinical study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteGermany
- Study dates
- 6 Mar 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed diagnosis of irritable bowel syndrome (IBS with diarrhea, IBS with constipation, mixed-type IBS, or unspecified IBS); IBS-SSS Score > 75
Who cannot join
- Severe mental illness (e.g., clinically significant depression, substance use disorder, schizophrenia)
- Severe comorbid somatic illness (e.g., oncological disease)
- Pregnancy
- Participation in other stress reduction programs or clinical studies on psychological interventions
- Known intolerances (fructose, lactose), celiac disease, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Sozialstiftung Bamberg
Bamberg, Bavaria, 96049
Jost Langhorst, Prof. Dr., +49 951 503 ext. 11650, FIGN@sozialstiftung-bamberg.de
About this study
Official title: Effect of a Stress Reduction and Lifestyle Modification Programme on the Quality of Life of Irritable Bowel Syndrome Patients (MBM IBS)
In the planned efficacy study, a prospective randomized controlled trial will be conducted to investigate the extent to which a multimodal stress reduction and lifestyle modification program can be reflected in patients with irritable bowel syndrome (IBS) within the framework of a clinical study. For this purpose, 118 patients with IBS will be enrolled in a clinical study. The intervention group will participate in a partial outpatient multimodal stress reduction and lifestyle modification program over 10 weeks, while the waitlist control group will only receive an educational session and written information on treatment and self-help options. The primary research question encompasses the examination of the program's impact on the severity of symptoms associated with irritable bowel syndrome (measured with the IBS-Symptom Severity Scale [IBS-SSS]) and additionally its influence on quality of life, stress, and mental well-being. Another aspect of the study is the utilization of medical services (e.g., comparing the number of doctor visits; intake of prescribed and over-the-counter medications). Additionally, a comparison of days of work disability will be conducted.
Read the detailed description
The intervention is a 10-week multimodal stress reduction and lifestyle modification program consisting of 10 sessions, each lasting 6 hours. In groups of around 10 individuals, patients are comprehensively trained on the interplay between lifestyle and health, stress management, moderate physical activity (including yoga and Tai Chi), a Mediterranean diet, and self-help strategies. Successfully tested in two pilot studies, the program has evolved over 15 years and gained clinical experience in chronic inflammatory bowel diseases. It is now being applied to patients with irritable bowel syndrome (IBS).
Built on concepts like the Mind-Body Program and mindfulness-based stress reduction, the intervention incorporates elements from salutogenic and transtheoretical models and psychotherapeutic approaches.
Few integrative medicine approaches for IBS have undergone rigorous evaluation. IBS patients often experience reduced quality of life due to stress and psychosocial symptoms. The program, proven effective in inflammatory bowel diseases, covers stress reduction, dietary improvement, physical activity promotion, self-care applications, coping strategy training, and naturopathic treatments. Medically supervised, the group setting aims to enhance the intervention's impact through mutual support. Practical skills are demonstrated, and the goal is to empower patients for active, responsible, long-term management.
Participants in the waitlist control group receive a 1,5-hour educational session on lifestyle factors' influence and self-help materials. After week 36 measurements, they are offered participation in the multimodal program.
Questionnaires, a diary, and interviews will measure the outcomes of the study. Sociodemographics will be collected.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- lifestyle modification, waitlist control group
- Keywords
- lifestyle modification, Mind-Body medicine, integrative medicine
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle modificationBehavioural
The group intervention is carried out once a week for 10 weeks for a total of 60 hours with elements of mindfulness-based stress reduction (MBSR) and mind / body medicine. In this project, this program will be adapted to the specific needs of irritable bowel syndrome patients.
waitlist control groupBehavioural
Participants in this group receive a one-time education unit within the scope of 1,5 hours on the influence of lifestyle factors on the disease, also self-help materials for independent training offered. Following the follow-up measure also this group is given the opportunity to participate in the multimodal stress reduction- and lifestyle modification program.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Once a week for 10 weeks with a circumference of 60 hours with mindfulness-based stress reduction and further process of the Mind / body medicine. Receives: Behavioral: lifestyle modification |
| waitlist control group | Active comparator | A unique education unit within the scope of 1,5 hours on the influence of lifestyle factors on the disease and self-help materials for the independent training. After the follow-up measurement opportunity to participate in the program. Receives: Behavioral: waitlist control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of IBS symptoms by IBS-SSS
Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: < 175 for mild IBS, 175-300 for moderate IBS, and > 300 for severe IBS
Measured: week 0
Severity of IBS symptoms by IBS-SSS
Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: < 175 for mild IBS, 175-300 for moderate IBS, and > 300 for severe IBS
Measured: week 12
Severity of IBS symptoms by IBS-SSS
Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: < 175 for mild IBS, 175-300 for moderate IBS, and > 300 for severe IBS
Measured: week 36
overall change in health status
Rating scale from 1 (= much worse) to 5 (= much better)
Measured: week 12
overall change in health status
Rating scale from 1 (= much worse) to 5 (= much better)
Measured: week 36
Secondary outcomes (27)
Disease related Quality of Life by IBS-QOL
The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. 34 items with a 5-point response scale from 1 (=not at all) to 5 (= Extremely/a great deal); 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.
Measured: week 0
Disease related Quality of Life by IBS-QOL
The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. 34 items with a 5-point response scale from 1 (=not at all) to 5 (= Extremely/a great deal); 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.
Measured: week 12
Disease related Quality of Life by IBS-QOL
The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. 34 items with a 5-point response scale from 1 (=not at all) to 5 (= Extremely/a great deal); 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.
Measured: week 36
General Quality of Life by EQ-5D-SL
The EQ-5D assesses health status in terms of five dimensions of health (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. 5-point response-scale from 1 (=not /no problems) to 5 (=unable to [mobility, self-care, usual activities]/extreme [pain/depression]/extremely [anxiety/depression]); result: 5-digit health status profile that represents that person's level of reported problems on the five EQ-5D health dimensions
Measured: week 0
General Quality of Life by EQ-5D-SL
The EQ-5D assesses health status in terms of five dimensions of health (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. 5-point response-scale from 1 (=not /no problems) to 5 (=unable to [mobility, self-care, usual activities]/extreme [pain/depression]/extremely [anxiety/depression]); result: 5-digit health status profile that represents that person's level of reported problems on the five EQ-5D health dimensions
Measured: week 12
General Quality of Life by EQ-5D-SL
The EQ-5D assesses health status in terms of five dimensions of health (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. 5-point response-scale from 1 (=not /no problems) to 5 (=unable to [mobility, self-care, usual activities]/extreme [pain/depression]/extremely [anxiety/depression]); result: 5-digit health status profile that represents that person's level of reported problems on the five EQ-5D health dimensions
Measured: week 36
Stress: Perceived Stress (PSS-10)
Perceived Stress Scale (PSS), Rating on a five-step scale from 1 (= never) to 5 (=very often), high stress is assumed from a total score of 20 points
Measured: week 0
Stress: Perceived Stress (PSS-10)
Perceived Stress Scale (PSS), Rating on a five-step scale from 1 (= never) to 5 (=very often), high stress is assumed from a total score of 20 points
Measured: week 12
Stress: Perceived Stress (PSS-10)
Perceived Stress Scale (PSS), Rating on a five-step scale from 1 (= never) to 5 (=very often), high stress is assumed from a total score of 20 points
Measured: week 36
Stress: Coping Strategies (CISS)
Short version of the Coping Inventory for Stressful Situations (24 items); Rating on a five-step scale from 1 (= not at all) to 5 (= very much); sum score for each coping strategy; higher scores indicate a greater use of that particular coping strategy
Measured: week 0
Stress: Coping Strategies (CISS)
Short version of the Coping Inventory for Stressful Situations (24 items); Rating on a five-step scale from 1 (= not at all) to 5 (= very much); sum score for each coping strategy; higher scores indicate a greater use of that particular coping strategy
Measured: week 12
Stress: Coping Strategies (CISS)
Short version of the Coping Inventory for Stressful Situations (24 items); Rating on a five-step scale from 1 (= not at all) to 5 (= very much); sum score for each coping strategy; higher scores indicate a greater use of that particular coping strategy
Measured: week 36
Core Self-Evaluation by CSES
Core Self-Evaluation (CSES), 12 items on five-point Likert scale, 1 indicates disagreement and 5 indicates full agreement. High scores on the CSES represents a positive, confident, and self-efficacious person
Measured: week 0
Core Self-Evaluation by CSES
Core Self-Evaluation (CSES), 12 items on five-point Likert scale, 1 indicates disagreement and 5 indicates full agreement. High scores on the CSES represents a positive, confident, and self-efficacious person
Measured: week 12
Core Self-Evaluation by CSES
Core Self-Evaluation (CSES), 12 items on five-point Likert scale, 1 indicates disagreement and 5 indicates full agreement. High scores on the CSES represents a positive, confident, and self-efficacious person
Measured: week 36
Utilization of medical services
Number of visits
Measured: week 0
Utilization of medical services
Number of visits
Measured: week 12
Utilization of medical services
Number of visits
Measured: week 36
Days of work disability
Number of days
Measured: week 0
Days of work disability
Number of days
Measured: week 12
Days of work disability
Number of days
Measured: week 36
Anxiety and depression by HADS
Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. high scores indicate depressivness and anxiety.
Measured: week 0
Anxiety and depression by HADS
Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. high scores indicate depressivness and anxiety.
Measured: week 12
Anxiety and depression by HADS
Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. high scores indicate depressivness and anxiety.
Measured: week 36
Qualitative Interviews
Qualitative interviews for gaining further insights into patients experiences
Measured: week 12
Adverse events
all adverse events
Measured: week 12
Adverse events
all adverse events
Measured: week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start6 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Bavarian State Ministry of Health and Care
- Responsible party
- Principal investigator, Jost Langhorst, Universität Duisburg-Essen
- Investigators
- Jost Langhorst, Prof. Dr., Principal investigator, University of Duisburg-Essen/Sozialstiftung Bamberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145022
- Sponsor's protocol ID
- 23065
- Status last verified
- Oct 2026
- First submitted
- 10 Nov 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Stress Reduction and Lifestyle Modification Programme on the Quality of Life of Irritable Bowel Syndrome Patients (MBM IBS)
- ClinicalTrials.gov ID
- NCT06145022
- Acronym / sponsor ID
- 23065
- Conditions
- Irritable Bowel Syndrome
- Keywords
- lifestyle modification, Mind-Body medicine, integrative medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Collaborators
- Bavarian State Ministry of Health and Care
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the planned efficacy study, a prospective randomized controlled trial will be conducted to investigate the extent to which a multimodal stress reduction and lifestyle modification program can be reflected in patients with irritable bowel syndrome (IBS) within the framework of a clinical study. For this purpose, 118 patients with IBS will be enrolled in a clinical study. The intervention group will participate in a partial outpatient multimodal stress reduction and lifestyle modification program over 10 weeks, while the waitlist control group will only receive an educational session and written information on treatment and self-help options. The primary research question encompasses the examination of the program's impact on the severity of symptoms associated with irritable bowel syndrome (measured with the IBS-Symptom Severity Scale [IBS-SSS]) and additionally its influence on quality of life, stress, and mental well-being. Another aspect of the study is the utilization of medical services (e.g., comparing the number of doctor visits; intake of prescribed and over-the-counter medications). Additionally, a comparison of days of work disability will be conducted.
Detailed description
The intervention is a 10-week multimodal stress reduction and lifestyle modification program consisting of 10 sessions, each lasting 6 hours. In groups of around 10 individuals, patients are comprehensively trained on the interplay between lifestyle and health, stress management, moderate physical activity (including yoga and Tai Chi), a Mediterranean diet, and self-help strategies. Successfully tested in two pilot studies, the program has evolved over 15 years and gained clinical experience in chronic inflammatory bowel diseases. It is now being applied to patients with irritable bowel syndrome (IBS).
Built on concepts like the Mind-Body Program and mindfulness-based stress reduction, the intervention incorporates elements from salutogenic and transtheoretical models and psychotherapeutic approaches.
Few integrative medicine approaches for IBS have undergone rigorous evaluation. IBS patients often experience reduced quality of life due to stress and psychosocial symptoms. The program, proven effective in inflammatory bowel diseases, covers stress reduction, dietary improvement, physical activity promotion, self-care applications, coping strategy training, and naturopathic treatments. Medically supervised, the group setting aims to enhance the intervention's impact through mutual support. Practical skills are demonstrated, and the goal is to empower patients for active, responsible, long-term management.
Participants in the waitlist control group receive a 1,5-hour educational session on lifestyle factors' influence and self-help materials. After week 36 measurements, they are offered participation in the multimodal program.
Questionnaires, a diary, and interviews will measure the outcomes of the study. Sociodemographics will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: lifestyle modificationOnce a week for 10 weeks with a circumference of 60 hours with mindfulness-based stress reduction and further process of the Mind / body medicine. |
| waitlist control group | Active comparator | Behavioral: waitlist control groupA unique education unit within the scope of 1,5 hours on the influence of lifestyle factors on the disease and self-help materials for the independent training. After the follow-up measurement opportunity to participate in the program. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- confirmed diagnosis of irritable bowel syndrome (IBS with diarrhea, IBS with constipation, mixed-type IBS, or unspecified IBS); IBS-SSS Score > 75
Key exclusion criteria (5 listed)
- Severe mental illness (e.g., clinically significant depression, substance use disorder, schizophrenia)
- Severe comorbid somatic illness (e.g., oncological disease)
- Pregnancy
- Participation in other stress reduction programs or clinical studies on psychological interventions
- Known intolerances (fructose, lactose), celiac disease, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifestyle modificationThe group intervention is carried out once a week for 10 weeks for a total of 60 hours with elements of mindfulness-based stress reduction (MBSR) and mind / body medicine. In this project, this program will be adapted to the specific needs of irritable bowel syndrome patients. | Behavioural | intervention group |
| waitlist control groupParticipants in this group receive a one-time education unit within the scope of 1,5 hours on the influence of lifestyle factors on the disease, also self-help materials for independent training offered. Following the follow-up measure also this group is given the opportunity to participate in the multimodal stress reduction- and lifestyle modification program. | Behavioural | waitlist control group |
Primary outcome
Severity of IBS symptoms by IBS-SSS
Time frame: week 0
Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: < 175 for mild IBS, 175-300 for moderate IBS, and > 300 for severe IBS
Severity of IBS symptoms by IBS-SSS
Time frame: week 12
Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: < 175 for mild IBS, 175-300 for moderate IBS, and > 300 for severe IBS
Severity of IBS symptoms by IBS-SSS
Time frame: week 36
Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: < 175 for mild IBS, 175-300 for moderate IBS, and > 300 for severe IBS
overall change in health status
Time frame: week 12
Rating scale from 1 (= much worse) to 5 (= much better)
overall change in health status
Time frame: week 36
Rating scale from 1 (= much worse) to 5 (= much better)
27 secondary outcomes
Disease related Quality of Life by IBS-QOL
Time frame: week 0
Disease related Quality of Life by IBS-QOL
Time frame: week 12
Disease related Quality of Life by IBS-QOL
Time frame: week 36
General Quality of Life by EQ-5D-SL
Time frame: week 0
General Quality of Life by EQ-5D-SL
Time frame: week 12
General Quality of Life by EQ-5D-SL
Time frame: week 36
Stress: Perceived Stress (PSS-10)
Time frame: week 0
Stress: Perceived Stress (PSS-10)
Time frame: week 12
Stress: Perceived Stress (PSS-10)
Time frame: week 36
Stress: Coping Strategies (CISS)
Time frame: week 0
Stress: Coping Strategies (CISS)
Time frame: week 12
Stress: Coping Strategies (CISS)
Time frame: week 36
Core Self-Evaluation by CSES
Time frame: week 0
Core Self-Evaluation by CSES
Time frame: week 12
Core Self-Evaluation by CSES
Time frame: week 36
Utilization of medical services
Time frame: week 0
Utilization of medical services
Time frame: week 12
Utilization of medical services
Time frame: week 36
Days of work disability
Time frame: week 0
Days of work disability
Time frame: week 12
Days of work disability
Time frame: week 36
Anxiety and depression by HADS
Time frame: week 0
Anxiety and depression by HADS
Time frame: week 12
Anxiety and depression by HADS
Time frame: week 36
Qualitative Interviews
Time frame: week 12
Adverse events
Time frame: week 12
Adverse events
Time frame: week 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jost Langhorst, Prof. Dr. principal investigator
University of Duisburg-Essen/Sozialstiftung Bamberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle modification in people with Irritable Bowel Syndrome, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Utz, PhD (+49 951 503 ext. 16926, sandra.utz@sozialstiftung-bamberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of IBS symptoms by IBS-SSS (time frame: week 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.